Device Classification Name |
stimulator, transcutaneous electrical, aesthetic purposes
|
510(k) Number |
K173093 |
Device Name |
TAMA BEMS device |
Applicant |
TAMA Research Corporation |
7600 North 16th Street, |
Suite 205 |
Phoenix,
AZ
85020
|
|
Applicant Contact |
Ali Shambayati |
Correspondent |
Medical Devices Academy, Inc. |
345 Lincoln Hill Road |
Shrewsbury,
VT
05728
|
|
Correspondent Contact |
Robert Packard |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 09/29/2017 |
Decision Date | 06/05/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|